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Novartis Terminates Agreement with Mesoblast (MSB)

December 14, 2021 5:57 AM EST

Mesoblast Limited (Nasdaq: MESO), global leader in allogeneic cellular medicines for inflammatory diseases, was notified today by Novartis that it has chosen to terminate the agreement with Mesoblast prior to closing. Mesoblast remains highly focused on executing on our short term objective to bring remestemcel-L to market for patients with acute respiratory distress syndrome (ARDS) due to COVID-19.

The observed mortality reduction with remestemcel-L in patients aged under 65 in the completed COVID ARDS trial, despite having missed the primary endpoint, is considered by Mesoblast to be a sufficiently strong signal to support pursuing an emergency use authorization (EUA), the most direct path to market. Mesoblast is preparing to initiate a pivotal Phase 3 trial that may support a COVID ARDS EUA.

COVID-19 is likely to remain a serious global problem and to provide a major commercial opportunity for Mesoblast, with a steady state of intensive care unit (ICU) ARDS patients irrespective of vaccines and anti-viral treatments. Variants including Omicron present a growing threat due to increased infectivity and immune evasion from vaccines and monoclonal antibodies, increasing the urgent need for therapeutics to prevent the likely high mortality of those progressing to ICU and ARDS.



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